# K882214: Simplastin Excel S

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Jul 1, 1988 after 36 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 23, 2002 · Not classified · Z-0628-03: Vial to vial variability which can result in prolonged clot times.

Source page: https://510kreport.com/device/K882214
Methodology: https://510kreport.com/methodology